Reservoir connector

ABSTRACT

Apparatuses and methods for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump are provided. A base is provided which is adapted to receive a reservoir and engage a cap. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base is in a first detent position, and the needle pierces a reservoir septum when the base is in a second detent position. When the reservoir, the base and the cap are connected to form an integrated unit, this unit is then capable of being inserted and secured in the infusion pump housing. In some embodiments, an integral connector couples directly to the reservoir.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This continuation-in-part application claims priority under 35U.S.C. §120 from U.S. patent application Ser. No. 09/428,818, filed Oct.28, 1999, and entitled “RESERVOIR CONNECTOR” which in turn claimspriority from U.S. Provisional Patent Application No. 60/106,237, filedon Oct. 29, 1998, both of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates generally to improvements in syringe orreservoir interfaces for use in infusion pumps such as those used forcontrolled delivery of medication to a patient. More specifically, thisinvention relates to an improved connection interface between areservoir or syringe and infusion set tubing or a standard luerconnector.

[0004] 2. Description of the Related Art

[0005] Infusion pump devices and systems are relatively well-known inthe medical arts, for use in delivering or dispensing a prescribedmedication such as insulin to a patient. In one form, such devicescomprise a relatively compact pump housing adapted to receive a syringeor reservoir carrying a prescribed medication for administration to thepatient through infusion tubing and an associated catheter.

[0006] The infusion pump includes a small drive motor connected via alead screw assembly for motor-driven advancement of a reservoir pistonto administer the medication to the user. Programmable controls arenormally provided for operating the drive motor continuously or atperiodic intervals to obtain a closely controlled and accurate deliveryof the medication over an extended period of time. Such infusion pumpsare utilized to administer insulin and other medications, with exemplarypump constructions being shown and described in U.S. Pat. Nos.4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, which are allincorporated by reference herein.

[0007] Infusion pumps of the general type described above have providedsignificant advantages and benefits with respect to accurate delivery ofmedication or other fluids over an extended period of time. The infusionpump can be designed to be relatively compact as well as waterresistant, and may thus be adapted to be carried by the user, forexample, by means of a belt clip. As a result, important medication canbe delivered to the user with precision and in an automated manner,without significant restriction on the user's mobility or life-style,including the ability to participate in water sports.

[0008] Infusion sets refer to the tubing and connection apparatus whichprovide a path for the medication to flow to the user from the reservoiror syringe located in the pump. The connectors for attaching theinfusion set tubing to the reservoirs can take various forms. A luerconnection is a commonly used connection method. Nevertheless, itremains desirable to develop improved designs of connection methods tofacilitate infusion procedures and to provide suitable interfaceconnections which are water resistant so as to permit a user toparticipate in water sports.

SUMMARY OF THE INVENTION

[0009] The invention disclosed herein has a number of embodiments. Atypical embodiment of the invention is an apparatus for connecting areservoir having a septum and a base to a conduit, such as infusion settubing. In certain aspects of the present invention, the apparatuscomprises a cap and a releasable coupler which is adapted to releasablycouple the base to the cap in one of two positions. A piercing member,such as a needle, is coupled to the conduit. The needle is disposed inthe cap in a position other than the interior of the reservoir when thebase is in the first position. The needle is further disposed to piercethe reservoir septum when the base is in the second position.

[0010] In another embodiment, the apparatus is used for connecting areservoir having a septum and a base to a housing as well as to aconduit. The housing has a housing engagement member, such as a thread.The apparatus comprises a cap and a releasable coupler which is adaptedto releasably couple the base to the cap in one of two positions. Apiercing member, such as a needle, is releasably coupled to the conduit.The needle is disposed in the cap in a position other than the interiorof the reservoir when the base is in the first position. The needle isfurther disposed to pierce the reservoir septum when the base is in thesecond position. The cap further includes an engagement member, such asa thread, which is adapted to engage with the housing engagement member.

[0011] In another embodiment, the cap further includes a vent port whichis covered with hydrophobic material. This permits air to pass throughthe cap while preventing water from doing so.

[0012] In another embodiment, an integral apparatus is used forconnecting a reservoir having a septum and an annular shoulder and aconduit. This embodiment includes a conduit portion, a piercing membercoupled to the conduit and adapted to pierce the septum and a reservoirconnector portion coupled to the conduit portion and comprising anopen-ended cylindrical member. The open-ended cylindrical member isreleasably coupleable to the reservoir and the piercing member piercesthe septum when so coupled. Typically, the conduit is a luer connector.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Referring now to the drawings in which like reference numbersrepresent corresponding parts throughout:

[0014]FIG. 1 is an exploded, perspective view of a medication reservoirconnection interface apparatus;

[0015]FIG. 2 is a perspective view of a cap used as a medicationreservoir connection interface apparatus;

[0016]FIG. 3 is an exploded, perspective view of an alternativeembodiment of a medication reservoir connection interface apparatus;

[0017]FIG. 4 is a side, cut-away view of a cap used as a medicationreservoir connection interface apparatus;

[0018]FIG. 5 is a side, plan cut-away view of a medication reservoirconnection interface apparatus with a needle inserted into a reservoir;

[0019]FIG. 6 is a side, plan cut-away view of a medication reservoirconnection interface apparatus which is inserted into a pump housing;

[0020]FIG. 7 is a perspective view of an alternative embodiment of amedication reservoir connection interface apparatus;

[0021]FIG. 8 is a perspective top view of an alternative embodiment of amedication reservoir connection interface apparatus which is securedinto a pump housing;

[0022]FIG. 9 is a perspective view of an alternative embodiment of amedication reservoir connection interface apparatus;

[0023]FIG. 10 is an exploded, perspective view of a cap used as amedication reservoir connection interface apparatus;

[0024]FIG. 11 is a perspective view of a medication reservoir connectioninterface adapter;

[0025]FIG. 12 is a cross-sectional view of a medication reservoirconnection interface adapter;

[0026]FIG. 13 is a perspective view of an alternative embodiment of acap used as a medication reservoir connection interface apparatus;

[0027] FIGS. 14A-14C are cross-sectional views of various embodiments ofventing ports for use with a reservoir connection interface apparatus oradapter;

[0028]FIG. 15 is an exploded, perspective view of an embodiment of anintegral medication reservoir connection apparatus and a reservoir;

[0029] FIGS. 16A-16C are views of an integral medication reservoirconnection embodiment;

[0030] FIGS. 17A-17D are views of another embodiment of an integralmedication reservoir connection embodiment;

[0031] FIGS. 18A-18C are views of an another embodiment of an integralmedication reservoir connection embodiment without a neck portion.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0032] In the following description, reference is made to theaccompanying drawings which form a part hereof and which illustrateseveral embodiments of the present invention. It is understood thatother embodiments may be utilized and structural and operational changesmay be made without departing from the scope of the present invention.

[0033] As shown in the drawings for purposes of illustration, theinvention is embodied in an interface for connecting a syringe or amedication reservoir to a conduit, such as infusion set tubing or anexternal needle, as well as to an infusion pump. In one embodiment, abase is provided which is adapted to receive a reservoir. A cap isprovided which is adapted to be releasably coupled to the base in one oftwo positions. The releasable coupler comprises a pair of detentsprojecting from the base and two pairs of detent openings in the capwhich are adapted to removably engage the base detents.

[0034] A piercing member, such as a needle, is disposed in the interiorof the cap in such a manner that the needle is separated from thereservoir septum when the base detents are in the first pair of capdetent openings, and the needle pierces the reservoir septum when thebase detents are in the second pair of cap detent openings. When thereservoir, the base and the cap are connected, an integrated unit isformed which is then capable of being inserted in the infusion pumphousing. Engagement members, such as threads, for the cap and the pumphousing are used to secure the integrated unit in the housing.

[0035] In another embodiment, an integral apparatus is used forconnecting a reservoir having a septum and an annular shoulder and aconduit. The apparatus comprises a conduit portion, a piercing membercoupled to the conduit and adapted to pierce the septum and a reservoirconnector portion coupled to the conduit portion and comprising anopen-ended cylindrical member. The open-ended cylindrical member isreleasably coupleable to the reservoir and the piercing member piercesthe septum when so coupled. Typically, the conduit is a luer connector.

[0036]FIGS. 1 and 2 show an infusion set connector interface forattachment to a medication reservoir. The connector interface iscomprised of a base 2 and a cap 4. The cap 4 includes a needle 9 locatedinternal to the cap housing. FIG. 1 is an exploded view, and therefore,the base 2 would normally be fixedly attached to a reservoir 1 bysecuring it around the swage 3, which holds the reservoir septum.However, alternative embodiments of the present invention include aremovable base so that the connector interface could be used withstandard reservoirs, cartridges or syringes which were not initiallymanufactured with the base attached.

[0037] The cap 4 portion of the connector interface is removablyattached to the base 2 with a releasable coupler. In one embodiment, thereleasable coupler is comprised of detents formed on the base 2 anddetent openings disposed in the cap 4. Two detents 8 are disposed on thesides of the base 2 and are spaced 180° radially apart. Only one detent8 is shown in FIG. 1. The detents 8 are sized to fit in the two lowerdetent openings 6, or alternatively, in the two upper detent openings 7which are formed in the cap 4. As with the pair of detents 8, each ofthe lower detent openings 6 and each of the upper detent openings 7,respectively, are radially spaced apart by 180°.

[0038] In operation, the base 2 and the reservoir 1 form an integratedunit which in turn is to be connected to the cap 4. In connecting thisintegrated base/reservoir unit to the cap 4, the base 2 is inserted intothe lower end of the cap 4 until the detents 8 snap into the lowerdetent openings 6. This is accomplished by moving the detents 8 overinternal cam surfaces 10 toward the lower detent openings 6. The camsurfaces act as ramps which compress the detents 8 sufficiently topermit them to snap into the lower detent openings 6. Internal threads10 a guide the detents 8 into position.

[0039] When the base/reservoir unit is in this first, lower position,the needle 9 is positioned apart from the septum (not shown) of thereservoir 1. Thus the needle does not pierce the septum while thebase/reservoir unit is in this first position. When the base/reservoirunit is connected to the cap in this fashion, an integratedcap/base/reservoir unit is thereby formed. Conveniently, such anintegrated cap/base/reservoir unit can be sold or stored for longperiods of time in this fashion. Alternatively the end user can assemblethis unit shortly prior to placing it in the pump for use.

[0040] When the user desires to insert the cap/base/reservoir unit inthe pump housing and commence dispensing the medication through aconduit, such as insertion set tubing 5, the base 2 is moved to thesecond position within the cap 4. This is accomplished by twisting thebase/reservoir unit while pushing it further into the cap 4. The detents8 disengage from the lower detent openings 6 and engage into the upperdetent openings 7. Additional internal threads 10 a of the cap 4 serveto guide the detents 8 over additional cam surfaces 10 from their firstposition in the lower detent openings 6 to the second position in theupper detent openings 7.

[0041] In one embodiment, the threads and the spacing between the lowerdetents 6 and the upper detents 7 is such that a one quarter (¼) turn ofthe base will cause the base/reservoir unit to travel from the first tothe second position. The needle 9 is disposed so that when thebase/reservoir unit is in the second position, the needle pierces theseptum of the reservoir 1. Thus the movement of the base/reservoir unitfrom the first to the second position within the cap serves to cause theneedle to pierce the reservoir's septum, thus permitting the fluid inthe reservoir to flow into the needle 9 and the insertion set tubing 5.

[0042] After this connection is made, the reservoir, base and cap form aunit which can be releasably secured in the housing of a medicationinfusion pump (not shown). Detents 4 a extend radially from the exteriorof the cap and are adapted to engage into detent openings (not shown) inthe pump housing. In an alternative embodiment, the cap 4 can includeexternal threads (not shown) which are used to engage the threads of thepump housing in order to secure the reservoir/base/cap unit into thehousing.

[0043]FIGS. 3 and 4 show an alternative embodiment of the infusion setconnector interface. The connector interface is comprised of a base 11and a cap 12. The cap 12 includes a needle 18 located internal to thecap housing (FIG. 4). The base 11 would normally be fixedly attached tothe reservoir 1 by securing it around the swage 3. However, alternativeembodiments of the present invention include a removable base so thatthe connector interface could be used with standard reservoirs,cartridges or syringes which were not initially manufactured with thebase attached.

[0044] The cap 12 portion of the connector interface is removablyattached to the base 11 with a releasable coupler. In this embodiment,the releasable coupler is comprised of detents 15 formed on the base 11and detent openings disposed in the cap 12. Two detents 13 are disposedon the sides of the base 11 and are spaced 180° radially apart. Only onedetent 13 is shown in FIG. 3. The detents 13 are sized to fit in twodetent openings 14 which are formed in the cap 12. As with the pair ofdetents 13, each of the detent openings 14 are radially spaced apart by180°.

[0045] In operation, the base 11 and the reservoir 1 form an integratedunit which in turn is to be connected to the cap 12. In connecting thisintegrated base/reservoir unit to the cap 12, the base 11 is insertedinto the lower end of the cap 12. The detents 13 slide into matinglyshaped and longitudinally open entry slots 15 formed within the interiorwalls of the cap 12. When the base 11 is fully inserted in the cap 12,the leading edges of the detents 13 abut an annular stop shoulder 16formed within the cap 12. After the detents 13 are in this position, thebase 11 is rotated within the cap 12 toward a locked position. Referringto FIG. 4, this rotation displaces the detents 13 in a rotationaldirection for engagement with cam surfaces 17 formed within the cap 12.The rotational force on the detents 13 over the cam surfaces 17 providesa compression force on the detents 13. Continued rotation of the base 11displaces the detents 13 past the cam surfaces 17 and into alignmentwith the detent openings 14. The detents 13 enter the detent openings 14with a snap-action. Thus, the detents 13 are effectively locked withinthe detent openings 14 to prevent longitudinal separation of the base 11from the cap 12.

[0046] In the preferred embodiment, the internal needle 18 of the cap 12is disposed so that when the base/reservoir unit is fully inserted inthe cap 12, the needle pierces the septum (not shown) of the reservoir1. Thus the insertion force of the base/reservoir unit to the pointwhere the detents 13 abut the annular stop shoulder 16 causes the needle18 to pierce the septum, thus permitting the fluid in the reservoir toflow into the needle 18 and the insertion set tubing (not shown).

[0047] After this connection is made, the reservoir, base and cap form aunit which can be releasably secured in the housing of a medicationinfusion pump. (not shown) The cap 12 includes external threads 19 whichare used to engage the threads of the pump housing in order to securethe reservoir/base/cap unit into the housing. In the preferredembodiment, the threads 19 have an eight threads per inch (“TPI”), 2start profile. Moreover, they have a square shaped cross section whichmaximizes their holding strength. Other thread profiles andcross-sections may be used however.

[0048] When disconnection of the base 11 from the cap 12 is desired, thebase 11 must be reverse-rotated within the cap 12, to move the detents13 past the cam surfaces 17 into re-alignment with the entry slots 15.Such reverse-rotation of the coupler can be performed relatively easily,but essentially requires an affirmative intent by the user to disconnectthe coupling. When the detents 13 are re-aligned with the entry slots15, the cap 12 and base 11 can be separated easily with minimallongitudinal force.

[0049]FIG. 5 shows a cross sectional view of the reservoir/base/capintegrated unit in accordance with the embodiment of FIGS. 3 and 4. Thereservoir 1 includes a crimp seal swage 3 which encloses the outerperiphery of the rubber septum 20 in order to secure the septum 20 tothe reservoir 1 and form a water tight seal. With the base 11 in thelocked position as shown, the detents 13 of the base 11 are locked intothe detent openings 14 to securely attach the base/reservoir unit intothe cap 12. The needle 18 pierces the rubber septum 20, thus permittingthe flow of liquid through the needle 18 and into the infusion settubing cavity 22. Infusion set tubing (not shown) is secured into thecavity 22 to allow the liquid to continue its flow to the user.

[0050] In the preferred embodiment, the conduit from the cap 12 isinfusion set tubing. However in an alternative embodiment, the conduitcomprises a second needle (not shown). This is secured into the cavity22 with the point of the second needle extending outward. With thisarrangement, the connector serves as an apparatus for permitting therefilling of the reservoir 1. The second, external needle would piercethe septum of a supply vial of fluid. The fluid could then be drawn intothe cap in a reverse flow and into the reservoir 1 via the internalneedle 18.

[0051] In the embodiment shown in FIG. 5, infusion set tubing is securedto the cavity 22 to allow liquid to flow to the user. The cavity 22 isdisposed in the raised portion of the cap 12. In an alternativeembodiment, however, the raised portion of the cap 12 can be in theshape of a standard luer fitting 47 shown in FIG. 13.

[0052] Referring to FIG. 5, in one embodiment the base 11 is formedaround and fixedly attached to the crimp seal swage 3 portion of thereservoir 1. In an alternative embodiment, however, the base 11 is notfixedly attached to the reservoir. Rather, the base 11 is a separateunit which is adapted to be releasably secured to the reservoir via afriction fit. This arrangement permits the connector apparatus to beused with standard reservoirs.

[0053] Still referring to FIG. 5, the cap 12 includes threads 19 forsecuring the assembly into the pump housing (not shown). A shoulder 23is formed as part of the cap 12 and is adapted to seat against the pumphousing to form a water tight seal. This prevents any water which isexterior to the housing from entering, thus permitting the user toengage in water sports.

[0054] The construction of these pumps to be water resistant can giverise to operational problems. As the user engages in activities whichexpose the pump to varying atmospheric pressures, such as for example,swimming or traveling in an airplane, differential pressures can arisebetween the interior of the air tight/water-resistant housing and theatmosphere. Should the pressure in the housing exceed externalatmospheric pressure, the resulting forces could cause the reservoirpiston to be driven inward thus delivering unwanted medication.Alternatively, should the pressure in the housing be less than theexternal pressure, the resulting forces could cause the infusion pumpmotor to work harder to advance the reservoir piston.

[0055] To address this problem, a preferred embodiment of the inventionincludes a vent which permits water resistant housing construction. Thecap 12 includes a plurality of vent ports 24, only one of which is shownin FIG. 5. The vent ports 24 permit equalization of pump housingpressure to atmospheric pressure. Hydrophobic material (not shown)covers the interior openings of the vent ports 24. Hydrophobic materialpermits air to pass through the material while preventing water or otherliquids from doing so, thus permitting water resistant venting. Thepreferred embodiment uses a hydrophobic material such as Gore-Tex®,PTFE, HDPE, or UHMW polymers from sources such as W. I. Gore &Associates, Flagstaff, Ariz., Porex Technologies, Fairburn, Ga., DeWALIndustries, Saunderstown, R.I., or Pall Specialty Materials, PortWashington, N.Y.

[0056] These materials are available in sheet form or molded (press andsintered) in a geometry of choice. Referring to FIGS. 14A-14C, preferredmethods to attach this material to the cap 12 include molding thehydrophobic material into a sphere 50 (FIG. 14A) or a cylinder 51 (FIG.14B) and pressing it into a cavity in the pre-molded plastic housing.Alternatively, a label 52 (FIG. 14C) of this material could be made witheither a transfer adhesive or heat bond material 53 so that the labelcould be applied over the vent port 24. Alternatively, the label couldbe sonically welded to the housing. In either method, air will be ableto pass freely, but water will not.

[0057] In an alternative embodiment which is not shown, the venting isaccomplished through a vent port located in the pump housing. This isdescribed in greater detail in copending U.S. patent application Ser.No. 09/429,352, filed Oct. 28, 1999, which application is incorporatedby reference in its entirety. Alternatively, vent ports can be placedboth in the cap 12 as well as the pump housing.

[0058] An advantage of placing the vent port and hydrophobic material inthe cap 12, as opposed to in the pump housing only, is that the infusionset and its related connectors are disposable and are replacedfrequently with each new reservoir or vial of medication. Thus, newhydrophobic material is frequently placed into service. This providesenhanced ventilation as compared with the placement of hydrophobicmaterial in only the pump housing. Material in this location will not bereplaced as often and thus is subject to dirt or oil build up which willretard ventilation.

[0059] As an alternative to the use of hydrophobic material, water canbe prevented from flowing through the vent port by other apparatuses,such as the use of relief valves.

[0060]FIG. 6 shows a cross-sectional view of the reservoir/base/cap unitin accordance with the embodiment of FIGS. 3 and 4 which is secured intoa pump housing 30. The threads 19 of the cap 12 engage the pump housingthreads. Rather than the use of threads, an alternative embodiment (notshown) of the cap 12 could include detents extending radially from theexterior of the cap 12 which are adapted to engage detent openings inthe pump housing.

[0061] The shoulder 23 portion of the cap 12 seats against the pumphousing 30 to permit water tight construction. Further aiding in thewatertight construction is an O-ring seal 31 which is disposed in thepump housing 30 and located just above the shoulder 23. In the preferredembodiment, the vent material 32 is comprised of hydrophobic materialand is sonic welded to the upper interior surface of the cap 12.Alternatively, the vent material 32 could be attached to the cap 12 withan adhesive. The vent ports are not shown in FIG. 6.

[0062] Although the foregoing description of the venting was inconnection with the embodiment of FIGS. 3-6, this feature is alsoapplicable to the embodiment of FIGS. 1-2.

[0063]FIGS. 7 and 8 show an alternative embodiment of the cap 12.Referring to FIG. 7, a cap engagement member consists of a detent arm 34which is formed in the upper portion of the cap 12. The purpose of thedetent arm 34 is to securely engage the cap 12 into the pump housing.FIG. 8 shows a top view of the cap 12 positioned in the pump housing 30.The pump housing 30 has two case lock recesses 35 disposed in thecircular rim of the housing. The detent arm 34 snaps into either of thecase lock recesses 35. This engagement results in a “click” when the cap12 is appropriately seated, thus providing both tactile and audiblefeedback to the user that the cap is securely engaged in the pumphousing. Moreover, the detent arm 34 aligning with the recess 35 alsoserves as a visual indicator that the cap 12 is appropriately seated.

[0064]FIG. 9 shows an alternative embodiment of the cap 12 whichcontains a child safety feature. The cap 12 includes a locking memberwhich consists of a safety tab 36 disposed in a groove 37. The safetytab 36 is sized such that it is able to slide along the length of thegroove 37. When the safety tab 36 is in the position shown in FIG. 9,the detent arm 34 is unable to retract from its engaged position. Thuswhen the cap 12 is seated into the pump housing 30 (not shown) and thedetent arm is seated into the case lock recess 35 (not shown), thesafety tab 36 will prevent the detent arm 34 from disengaging from thecase lock recess 35 thus more securely locking the cap 12 in the pumphousing.

[0065] Thus for example, a parent could slide the safety tab 36 from theunlocked location in the groove 37 to the locked location shown in FIG.9 so that it would be more difficult for a young child or infant toinadvertently remove the cap/base/reservoir unit from the pump housing.On the other hand, when the safety tab 36 is moved to the opposite endof the groove 37, the detent arm 34 is able to retract thus permittingremoval of the cap 12 from the pump housing.

[0066] Although the foregoing description of the cap engagement memberand child safety tab was in connection with the embodiment of FIGS. 3-9,this feature is also applicable to the embodiment of FIGS. 1-2.

[0067]FIG. 10 shows an exploded view of the cap 12 and the vent material32. In the preferred embodiment, the vent material is made ofhydrophobic material and is formed in a circular shape with a circularhole in the center. The vent material 32 is attached to the upperinterior surface 38 of the cap 12 via sonic welding or an adhesive. Whenit is so attached, the needle 18 protrudes through the center hole ofthe vent material 32 but the interior openings of the vent ports 24 (notshown) are covered.

[0068]FIGS. 11 and 12 show an embodiment of the present invention wherean adapter 40 is provided to allow a standard style syringe 41 with anintegrated luer fitting 42 to be mounted and sealed in the pump housing.The syringe 41 is inserted through the center of the adapter 40 and heldinto place by a friction fit. The O-ring seal 43 in the adapter 40 seatsagainst the syringe wall in order to prevent water and dirt fromentering the pump housing.

[0069] A shoulder 45 is formed as part of the adapter 40 and is adaptedto seat against the interior of the pump housing to form a water tightseal. Two tabs 44 are formed on the top surface of the adapter 40 andprovide a surface for the user to grip the adapter 40 and twist it sothat the adapter threads 19 engage the threads (not shown) of the pumphousing. A detent arm 34 is formed in the upper portion of the adapter40. Its purpose is to securely lock the adapter 40 into the pump housing(not shown) in the same manner as is shown in FIG. 8. Although not shownin FIGS. 11 and 12, the adapter 40 can further contain vent portscovered with hydrophobic material or a relief valve in order to permitwater resistant venting of the pump housing in the same manner aspreviously described with other embodiments.

[0070]FIG. 13 shows another embodiment of the present invention where aninterface is provided to connect a reservoir to a conduit, such astubing, via a standard luer fitting connection. This allows a luer styledisposable infusion set to connect to the pump housing (not shown). Acap 46 is formed with a luer fitting 47 portion as an integral partthereof. Except for the shape of the luer fitting 47 portion, the cap 46has all of the other features of the cap 12 shown in FIG. 5. Thusreferring to FIG. 13, the cap 46 is comprised of, among other things,threads 19, detent openings 14, a shoulder 23, vent ports 24, a detentarm 34, and a needle (not shown) disposed in the interior of the cap 46.

[0071] While the embodiment of FIG. 13 includes a base member (notshown) to complete the connection of the cap 46 with a reservoir, otherembodiments of the invention perform this function using a singleintegrated unit. In an illustrative embodiment shown in FIG. 15 whichincludes a number of typical elements of the invention, a luer adapter51 is provided as a single, integral unit for connection to a standardprefilled cartridge or medication reservoir 52. The reservoir 52 iscomprised of a watertight cylinder 53 having a neck 54 with an opening(not shown) at the proximate end of the cylinder 53. A swage 55 havingan annular shoulder 56 is secured around the neck 54 of the cylinder 53.The swage 55 secures a rubber septum (not shown) over the opening (notshown) of the neck 54 thus providing a fluid-tight seal. The lueradapter 51 is comprised of a reservoir connector portion 57, a neckportion 58 and a male luer connector portion 59. The reservoir connectorportion 57 includes a piercing member or needle 60 which is adapted topierce the septum (not shown) of the reservoir 52 upon attaching it tothe luer adapter 51.

[0072] In an illustrative embodiment shown in FIGS. 16A-16C whichincludes a number of typical elements of the invention, the reservoirconnector portion 57 further comprises an open-ended cylindrical member61 having a base 62 which closes one end of the cylindrical member 61.The needle 60 is enclosed by the cylindrical member 61 and projectsaxially from the base 62. The length of extension of the needle 60 fromthe base is shorter than that of the cylindrical member 61 which servesto protect the needle 60 and to reduce the likelihood of accidentalneedle contact with the hands of users.

[0073] In the embodiment of FIGS. 16A-16C, the cylindrical member 61 hasa plurality of generally rectangular-shaped gaps 63 extending from theopen end of the member 61 to the base 62 thereby forming a plurality ofarms 64. To secure the luer adapter 51 to the reservoir 52, the arms 64can be snapped over the reservoir swage 55 (FIG. 15). Inwardlyprotruding tabs 65 are formed on the end of the arms 64 and are sized toengage the annular shoulder 56 of the reservoir swage 55 thus securingit to the luer adapter 51 in a snap-fit engagement. Moreover, as theluer adapter 51 is inserted over the swage 55, the needle 60 pierces thereservoir septum thus providing a fluid path from the reservoir to theluer fitting.

[0074] The snap fit engagement disclosed herein allows a user to quicklyand conveniently couple a reservoir to a specific interface, such as aluer, another snap-fit or any other fitting known in the art that ispresent on the conduit or device to which the reservoir is coupled. Asused herein, snap-fit as in “snap-fit engagement” refers to thereleasable coupling of a first member (e.g. the arm 64 of FIG. 16C) to asecond member (e.g. the swage 55 in FIG. 15) where a protrusion on thefirst member (e.g. the tab 65 on the arm 64 of FIG. 16C) typically ridesover a portion of the second member causing the first member totemporarily deflect until the protrusion on the first member is situatedin a receiving space on the second member (e.g. the annular shoulder 56of FIG. 15). Advantageously, this engagement typically results in a“click” when the first member is appropriately situated, thus providingboth tactile and audible feedback to the user that the first member issecurely engaged with the second member. Additional benefits of such anengagement include its facilitating a medical practitioner's ability toquickly and easily assemble an apparatus in situations where a patientrequires immediate medical intervention.

[0075] Embodiments having a single integral unit comprising a base and acap further reduce the amount of time needed to generate a fullyfunctional medical device because there is no need to separately couplea base to a reservoir before using the adapter. In addition, becausethis embodiment comprises a single integral unit rather than a compositeof multiple subunits, this design facilites both operator handling aswell as the maintainence of sterility. In addition, manufacturing issimplified because the device may be produced from a single mold.

[0076] In typical embodiment illustrated in FIGS. 16A-16C, thecylindrical member 61 is constructed of polyolefin or other materialwhich has sufficient flexibility to permit the arms 64 to flex and snapfit over the reservoir swage 55 yet further has sufficient strength tosecure the needle 60 in the luer adapter 51. Although the illustrativeembodiment shown in FIGS. 16A-16C has arms 64, other embodiments of thepresent invention include an open-ended cylinder member which has nogaps in the cylinder wall and therefore no arms. Utilizing a material ofappropriate flexibility, the cylinder member of such an embodiment isable to snap-fit over a reservoir swage. Furthermore, a balance may bestruck between the flexibility (or elasticity) of the selected materialand the number and dimensions (e.g. width and wall and tab thicknesses)of the arms 64 employed to obtain the design engagement feel. Inembodiments for which the open-ended cylindrical member includes noarms, the wall and tab thicknesses are selected in consideration of thematerial elasticity.

[0077] In another typical embodiment of the invention that isillustrated in FIGS. 16A-16C the male luer connector portion 59 of theluer adapter 51 is joined to the reservoir connector portion 57 by theneck portion 58. The neck portion 58 is cylindrically-shaped and has adiameter which is smaller than that of the reservoir connector portion57 as well as the male luer connector portion 59 of the luer adapter 51.The neck portion 58 is sized to fit within a housing of a medicationinfusion pump or any other apparatus so that the luer adapter 51 andreservoir 52 assembly can be secured therein. The male luer connectorportion 59 is a standard fitting comprising a luer collar 66 and a luertaper 67.

[0078] FIGS. 17A-17D show an another typical embodiment of an integralpiece luer adapter 81. In this embodiment, the adapter 81, operates inessentially the same manner as the embodiment of FIGS. 16A-16C, andcomprises a male luer connector portion 82 at one end, a reservoirconnector portion 83 at the opposite end, and a connecting neck portion84. The male luer connector portion 82 is a standard, known fittingwhich includes a luer collar 85, a luer taper 86 and threads 87 whichare on the internal surface of the luer collar 85. As illustrated inFIG. 17B, the connecting neck portion 84 is generally cylindrical inshape and has a first collar 89 which attached to the male luerconnector portion 82 as well as a second collar 90 which is attached tothe reservoir connector portion 83. A plurality of longitudinallyextending ribs 91 connect the first collar 89 with the second collar 90.A plurality of openings 92 which are defined by the ribs 91 expose aneedle 88 which extends from the male luer connector portion 82, throughthe neck portion 84 and to the reservoir connection portion 83. Theopenings 92 provide access by external devices which can be used to gripthe needle 88 during the assembly process. The needle 88 can be held inplace while a mold is being filled during this assembly. Although aplurality of openings is preferred, only one such opening 92 is includedto hold the needle 88.

[0079] In the embodiment of the invention illustrated in FIGS. 17A-17D,the reservoir connector portion 83 comprises an open-ended cylindricalmember 92 having a base 93 which closes one end of the cylindricalmember 92. The needle 88 is enclosed by the cylindrical member 92 andprojects axially from the base 93. The cylindrical member 92 has aplurality of generally rectangular-shaped gaps 94 extending from theopen end of the member 92 to the base 93 thereby forming a plurality ofarms 95. To secure the luer adapter 81 to a reservoir, the arms 95 canbe snapped over a swage of an industry standard reservoir. As seen inFIG. 17D, inwardly protruding tabs 96 are formed on the end of the arms95 and are sized to engage an annular shoulder of a standard reservoirswage thus securing it to the luer adapter 81 in a snap-fit engagementas previously described.

[0080] In the embodiment illustrated in FIGS. 17A-17D, the needle 88projects axially from the base 93 of the cylindrical member 92 andextends for a length which is shorter than the length of the arms 95.The opposite end of the needle 88 extends to the end of the luer taper86 thus providing a fluid flow path from a reservoir which may beattached to the reservoir connection portion 83 to infusion set tubingwhich may be attached to the luer connector portion 82. In oneembodiment (not shown), the end of the needle 88 which extends to theluer taper 86 can be tapered outwardly in order to more securely seatthe needle 88 in the luer adapter 81. Alternatively the needle 88 can begrit blasted in order to enhance the bonding to the body of the lueradapter 81, or the needle 88 can be assembled via an insertion moldingprocess or an epoxy bonding process.

[0081] In another illustrative embodiment (not shown), the needle 88does not extend to the end of the luer taper 86. Rather, the needle 88terminates inside of the luer taper 86 and a cylindrical cavity (notshown) within the luer taper 86 extends from the end of the needle 88 tothe exterior of the luer taper 86. This cavity can be sized to receive aneedle or other conduit from another device in order to provide a flowpath to refill a cartridge which may be attached to the reservoirconnection portion 83.

[0082] As illustrated in FIGS. 17B and 17C, the arms 95 are wider andthe gaps 94 are narrower than the arms 64 and the gaps 63 shown in theembodiment of FIGS. 16A-16C. As previously mentioned, the number anddimensions of the arms which are used to snap over the swage of astandard reservoir can be adjusted to accommodate the degree offlexibility of the material used to construct a cylindrical memberportion of a luer adapter.

[0083] FIGS. 18A-18C show yet another embodiment of the presentinvention. In this embodiment, a luer adapter 101 is comprised of areservoir connection portion 102 and a male luer connection portion 103.In contrast to the embodiments of FIGS. 16A and 17A, the luer adapter101 does not have a neck portion since one may not be needed for thoseapplications where it is not necessary for a luer adapter to be securedin a medication pump or other device in that fashion. However the lueradapter 101 does have a plurality of generally rectangular-shapedseating tabs 104 disposed on the reservoir connector portion 102. Thetabs 104 can be used to secure the luer adapter 101 in a medication pumpor other device housing. In other respects, the luer adapter 101operates in the same manner as the embodiments of FIGS. 16A and 17A.

[0084] Those skilled in the art will appreciate that while theembodiments of FIGS. 15-18 disclose an adapter for connecting a standardreservoir to a luer fitting as a typical embodiment of the invention,the invention disclosed herein is not limited to luer fittings. Instead,the design of the inventive adapter can be used for connecting astandard reservoir to one or more of the variety of other types offittings know in the art, such a swage or crimp fitting, threaded orunthreaded fittings, a nipple fitting or any other fitting known in theart without departing from the scope of the invention. By utilizing sucha design, the invention therefore serves as a universal adapter forconnecting elements such as a conduit to any one of a wide variety ofreservoirs known in the art.

[0085] While the description above refers to particular embodiments ofthe present invention, it will be understood that many modifications maybe made without departing from the spirit thereof. The accompanyingclaims are intended to cover such modifications as would fall within thetrue scope and spirit of the present invention. The presently disclosedembodiments are therefore to be considered in all respects asillustrative and not restrictive, the scope of the invention beingindicated by the appended claims rather than the foregoing description,and all changes which come within the meaning and range of equivalencyof the claims are therefore intended to be embraced therein. Allpatents, patent application and literature references identified hereinare incorporated herein by reference.

What is claimed is:
 1. An apparatus for connecting a reservoir having aseptum to a conduit, the apparatus comprising: a conduit portion; apiercing member coupled to the conduit portion and adapted to pierce theseptum; and a reservoir connector portion coupled to the conduit portionand comprising an open-ended cylindrical member; wherein the open-endedcylindrical member is releasably coupleable to the reservoir and thepiercing member pierces the septum when so coupled such that thepiercing member and the conduit portion can conduct a fluid.
 2. Theapparatus of claim 1, wherein the conduit portion comprises a luerconnector.
 3. The apparatus of claim 1, wherein the open-endedcylindrical member includes a base which closes one end of theopen-ended cylindrical member and the piercing member extends from thebase and is enclosed by the open-ended cylindrical member.
 4. Theapparatus of claim 1, wherein the open-ended cylindrical member has atleast one inwardly protruding tab which engages an annular shoulder ofthe reservoir in a snap-fit.
 5. The apparatus of claim 1, wherein theopen-ended cylindrical member comprises a plurality of arms, each armhaving an inwardly protruding tab which engages an annular shoulder ofthe reservoir in a snap-fit.
 6. The apparatus of claim 1, wherein thereservoir connector portion is coupled to the conduit portion by a neckportion comprising at least one opening for gripping the piercingmember.
 7. The apparatus of claim 1, wherein the reservoir connectorportion is coupled to the conduit portion by a neck portion adapted tosecure the apparatus in a housing.
 8. The apparatus of claim 1, whereinthe open-ended cylindrical member comprises a plurality of seating tabsfor securing the apparatus in a housing.
 9. A method of connecting areservoir having a septum to a conduit, comprising the steps of:releasably coupling a reservoir connector portion comprising anopen-ended cylindrical member to the reservoir, wherein the reservoirconnector portion is coupled to a conduit portion and the conduitportion is coupled to a piercing member; and piercing the septum withthe piercing member when releasably coupling such that the piercingmember and the conduit portion can conduct a fluid.
 10. The method ofclaim 9, wherein the conduit portion comprises a luer connector.
 11. Themethod of claim 9, wherein the open-ended cylindrical member includes abase which closes one end of the open-ended cylindrical member and thepiercing member extends from the base and is enclosed by the open-endedcylindrical member.
 12. The method of claim 9, wherein the open-endedcylindrical member has at least one inwardly protruding tab whichengages an annular shoulder of the reservoir in a snap-fit.
 13. Themethod of claim 9, wherein the open-ended cylindrical member comprises aplurality of arms, each arm having an inwardly protruding tab whichengages an annular shoulder of the reservoir in a snap-fit.
 14. Themethod of claim 9, wherein the reservoir connector portion is coupled tothe conduit portion by a neck portion comprising at least one openingfor gripping the piercing member.
 15. The method of claim 9, wherein thereservoir connector portion is coupled to the conduit portion by a neckportion adapted to secure the apparatus in a housing.
 16. The method ofclaim 9, wherein the open-ended cylindrical member comprises a pluralityof seating tabs for securing the apparatus in a housing.
 17. Anapparatus for connecting a reservoir having a septum to a conduit,comprising: a conduit means; a piercing means for piercing the septumcoupled to the conduit means; and a reservoir connector means coupled tothe conduit portion and comprising an open-ended cylindrical member;wherein the open-ended cylindrical member is releasably coupleable tothe reservoir and the piercing means pierces the septum when so coupledsuch that the piercing means and the conduit means can conduct a fluid.18. The apparatus of claim 17, wherein the conduit means comprises aluer connector.
 19. The apparatus of claim 17, wherein the open-endedcylindrical member includes a base which closes one end of theopen-ended cylindrical member and the piercing means extends from thebase and is enclosed by the open-ended cylindrical member.
 20. Theapparatus of claim 17, wherein the open-ended cylindrical member has atleast one inwardly protruding tab which engages an annular shoulder ofthe reservoir in a snap-fit.
 21. The apparatus of claim 17, wherein theopen-ended cylindrical member comprises a plurality of arms, each armhaving an inwardly protruding tab which engages an annular shoulder ofthe reservoir in a snap-fit.
 22. The apparatus of claim 17, wherein thereservoir connector portion is coupled to the conduit means by a neckportion comprising at least one opening for gripping the piercingmember.
 23. The apparatus of claim 17, wherein the reservoir connectormeans is coupled to the conduit means by a neck portion adapted tosecure the apparatus in a housing.
 24. The apparatus of claim 17,wherein the open-ended cylindrical member comprises a plurality ofseating tabs for securing the apparatus in a housing.